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Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study (SASOVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011358
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Brief Summary:
This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Obstructive Sleep Apnea Other: Sleeping Monitor Not Applicable

Detailed Description:

There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation.

The compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age.

They will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: case-control comparison study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Estimated Study Start Date : January 12, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Patient
Patient with Retinal Vein Occlusion
Other: Sleeping Monitor
to evaluate obstructive sleep apnea

Patient control
Patient with no Retinal Vein Occlusion
Other: Sleeping Monitor
to evaluate obstructive sleep apnea




Primary Outcome Measures :
  1. Apnea Hypopnea index >5/hour [ Time Frame: Hour 12 ]
    Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.


Secondary Outcome Measures :
  1. Berlin Questionnaire sleep test [ Time Frame: Hour 12 ]

    High Risk of Sleep Apnea Syndrome:

    If there are 2 or more Categories where the score is 2 or above

    Low Risk of Sleep Apnea Syndrome:

    If there is only 1 or no Categories where the score is 2 or above




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with an Retinal Vein Occlusion for one group (patients)
  • All patients with no Retinal Vein Occlusion for the other group (control)

Non-inclusion Criteria:

  • minor
  • Severe Insomnia
  • Neuromuscular Disease with respiratory muscle impairment
  • Chronic opioid medication
  • Pregnancy women.
  • Patient under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011358


Contacts
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Contact: Aurélie DESPUJOS 02.38.74.40.71 aurelie.despujols@chr-orleans.fr

Locations
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France
CHR d'Orléans
Orléans, France, 45067
Contact: Aurélie DESPUJOLS    02.38.74.40.71    aurelie.despujols@chr-orléans.fr   
Principal Investigator: Pierre BONICEL, Dr         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Pierre BONICEL, Dr CHR Orléans
Publications of Results:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04011358    
Other Study ID Numbers: CHRO-2018-14
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Retinal Vein Occlusion
central retinal vein occlusion
branch retinal vein occlusion
obstructive sleep apnea
sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Retinal Vein Occlusion
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases